zolpidem tartrate 12.5 mg
1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14) ]. Zolpidem tartrate extended-release tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )
breckenridge pharmaceutical, inc.
ROUND BLUE Z
Z ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING
ZOLPIDEM TARTRATE extended-release tablets, USP 6.25 mg are composed of two layers Layers are covered by the coating and are indistinguishable. and are pink, round, coated tablets debossed with "T" one side and plain on other side and supplied as: NDC Number Size 51991-981-01 bottle of 100
ZOLPIDEM TARTRATE extended-release tablets, USP 12.5 mg are composed of two layers and are blue, round, coated tablets debossed with "Z" one side and plain on other side and supplied as: NDC Number Size 51991-982-01 bottle of 100 Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).
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